SchizophreniaPhase 3NCT02287584
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
A Phase 3 study testing DSP-5423P 40mg, DSP-5423P 80mg and DSP-5423P Active-to-Flex in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 8 sites in 8 countries.
Trial summary
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- DSP-5423P 40mg, DSP-5423P 80mg and DSP-5423P Active-to-Flex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Dec 2014to Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria
- Patients who are aged 18 years or older at informed consent
- Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.
Who cannot join
- Patients who fall under a contraindication listed in the blonanserin (LONASEN) package insert
- Patients with Parkinson disease
- Patients who previously received blonanserin, etc.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- DSP-5423P Placebo, DSP-5423P 40mg, DSP-5423P 80mg, DSP-5423P Placebo-to-Flex, DSP-5423P Active-to-Flex
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-5423P PlaceboDrug
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DSP-5423P 40mgDrug
DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P 80mgDrug
DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Placebo-to-FlexDrug
DSP-5423P Placebo:
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Active-to-FlexDrug
DSP-5423P Active:
DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
| Study group | Role | What they receive |
|---|---|---|
| DSP-5423P Placebo | Placebo comparator | Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. Receives: Drug: DSP-5423P Placebo |
| DSP-5423P 40mg | Experimental | Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. Receives: Drug: DSP-5423P 40mg |
| DSP-5423P 80mg | Experimental | Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. Receives: Drug: DSP-5423P 80mg |
| DSP-5423P Placebo-to-Flex | Experimental | Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen. Receives: Drug: DSP-5423P Placebo-to-Flex |
| DSP-5423P Active-to-Flex | Experimental | Percutaneous Subjects received DSP-5423P 40mg or 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen. Receives: Drug: DSP-5423P Active-to-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PANSS Total Score From Baseline at Week 6
The Positive and Negative Syndrome Scale (PANSS) is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Measured: Week 6
Secondary outcomes (2)
Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
The Last Observation Carried Forward (LOCF) endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P.
Measured: Week 6 (LOCF)
Treatment Continuation Rate at 28 Weeks and 52 Weeks
Percentage of subjects who stay the study up to 28 weeks (196 days, all countries), and 52 weeks (364 days, in Japan) and its 95% confidence interval.
Measured: Open-Week 28 and Open-Week 52 in the open-label treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Drug Development Division, Study director, Sumitomo Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287584
- Sponsor's protocol ID
- D4904020
- Other IDs
- JapicCTI-142688
- Status last verified
- Apr 2022
- First submitted
- 6 Nov 2014
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Takekita Y, Matsumoto Y, Masuda T, Yoshida K, Koshikawa Y, Kato M. Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms. Neuropsychopharmacol Rep. 2024 Dec;44(4):784-791. doi: 10.1002/npr2.12490. Epub 2024 Oct 20.
PubMed 39428614
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Study of DSP-5423P in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02287584
- Acronym / sponsor ID
- D4904020
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 23 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DSP-5423P Placebo | Placebo comparator | Drug: DSP-5423P PlaceboPercutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. |
| DSP-5423P 40mg | Experimental | Drug: DSP-5423P 40mgPercutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. |
| DSP-5423P 80mg | Experimental | Drug: DSP-5423P 80mgPercutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen. |
| DSP-5423P Placebo-to-Flex | Experimental | Drug: DSP-5423P Placebo-to-FlexPercutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen. |
| DSP-5423P Active-to-Flex | Experimental | Drug: DSP-5423P Active-to-FlexPercutaneous Subjects received DSP-5423P 40mg or 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria
- Patients who are aged 18 years or older at informed consent
- Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.
Key exclusion criteria (3 listed)
- Patients who fall under a contraindication listed in the blonanserin (LONASEN) package insert
- Patients with Parkinson disease
- Patients who previously received blonanserin, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSP-5423P PlaceboDSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily | Drug | DSP-5423P Placebo |
| DSP-5423P 40mgDSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily | Drug | DSP-5423P 40mg |
| DSP-5423P 80mgDSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily | Drug | DSP-5423P 80mg |
| DSP-5423P Placebo-to-FlexDSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily | Drug | DSP-5423P Placebo-to-Flex |
| DSP-5423P Active-to-FlexDSP-5423P Active: DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily | Drug | DSP-5423P Active-to-Flex |
Primary outcome
Change in PANSS Total Score From Baseline at Week 6
Time frame: Week 6
The Positive and Negative Syndrome Scale (PANSS) is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
2 secondary outcomes
Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Time frame: Week 6 (LOCF)
Treatment Continuation Rate at 28 Weeks and 52 Weeks
Time frame: Open-Week 28 and Open-Week 52 in the open-label treatment phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39428614Takekita Y, Matsumoto Y, Masuda T, Yoshida K, Koshikawa Y, Kato M. Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms. Neuropsychopharmacol Rep. 2024 Dec;44(4):784-791. doi: 10.1002/npr2.12490. Epub 2024 Oct 20.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director, Drug Development Division study director
Sumitomo Pharma Co., Ltd.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DSP-5423P 40mg, DSP-5423P 80mg and DSP-5423P Active-to-Flex in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Japan, Malaysia, Philippines, Russia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PANSS Total Score From Baseline at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02287584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.